Unilife Appoints Unifill(TM) Automated Assembly Line Supplier
November 19 2009 - 9:12AM
Marketwired
Unilife Medical Solutions Limited ("Unilife" or "the Company")
(ASX: UNI)(PINKSHEETS: UNIFF) today announced the appointment of
Mikron Group ("Mikron") as its contracted supply partner for the
development and supply of automated assembly systems to support the
commercial production of the Unifill(TM) ready-to-fill syringe
(Unifill(TM) syringe).
Mikron is a Swiss-based international leader for manufacturing
technology and assembly automation. They employ 1,000 staff
worldwide, and specialise in high-performance assembly and test
solutions for the medical device, pharmaceutical, automotive supply
and electronics markets.
During the past 30 years, the Mikron Assembly Technology
Division has developed more than 2,000 assembly systems. Many of
these were contracted for supply by pharmaceutical and healthcare
equipment companies to manufacture medical devices that included
inhalers, pen injectors, safety syringes and insulin pens. They
also have extensive experience in the development of automated
assembly systems for ready-to-fill glass barrels used in the
production of prefilled syringes.
After an extensive due diligence process, Unilife has engaged
Mikron to develop and supply the automated assembly lines that will
be used in the production of the Unifill(TM) syringe. The first
Unifill(TM) commercial line will have a target production capacity
of approximately 60 million units per year, which is 50% greater
than originally anticipated when the industrialisation program
first commenced in July 2008.
The development of this commercial line is expected to commence
next month, with its scheduled installation into Unilife's new
production facility in Pennsylvania during the fourth quarter of
2010. This commercial line will support the completion of the
Unifill(TM) industrialisation program which Unilife is currently
undertaking in conjunction with its major pharmaceutical
partner.
After the successful validation of the first commercial assembly
line, Unilife expects to work with Mikron on the development of a
high-volume line. This high-volume assembly line, which will have a
target annual production capacity of 150 million units per year, is
scheduled for installation at Unilife's new production facility
towards the end of 2011.
Following the installation of both the commercial and
high-volume assembly lines, Unilife would have a total production
capacity for the Unifill(TM) syringe of more than 200 million units
per year. Subject to the successful development and supply of these
assembly lines to contract specifications by Mikron, Unilife
expects that it will order additional high-volume lines to meet
ongoing pharmaceutical demand for its ready-to-fill safety
syringes.
To optimize production scalability and minimize operational
risk, both lines will utilize a modular assembly platform which has
been successfully applied by Mikron across several hundred previous
projects. Prior to the appointment of Mikron as the contracted
supplier of automated assembly systems for Unilife, they were
required to undertake a number of proof-of-principle activities to
validate that their modular assembly platform was capable of
assembling the Unifill(TM) syringe at speeds equivalent to those
targeted for the high-volume line. As part of proof-of-principle
activities undertaken by Mikron, the Unifill syringe was
successfully produced at desired speeds using the same assembly
system station that will serve as the platform for the commercial
and high-volume assembly lines. Multiple versions of these
scalable, industry-accepted and highly flexible stations will be
integrated into each commercial and high-volume assembly line to be
developed by Mikron to attain Unilife's target production volumes.
This process of replicating an already proven assembly system has
helped to significantly de-risk the path towards high-volume
commercial production of the Unifillâ„¢ Syringe.
Comments by CEO Alan Shortall
"It has been a key business priority for Unilife this year to
select our contract partner for the development of automated
systems to assemble our Unifill(TM) syringes at commercial levels.
After carefully considering and evaluating several high quality
potential suppliers, Mikron was chosen because it has a strong and
proven background within the highly-specialized pharmaceutical
market for injectable drug delivery devices.
"Mikron has direct experience with developing assembly systems
for ready-to-fill syringes. As an established industry leader with
strong relationships with a number of pharmaceutical companies,
they also have sufficient resources to accommodate our aggressive
production ramp plans. Most importantly, we have validated that our
Unifill(TM) syringes can be assembled using their proven technology
systems at commercially sustainable levels. From here, the path to
high-volume commercial production is a scheduled process of
replication rather than a complex technical challenge. We believe
the appointment of Mikron to be a safe choice that will
significantly de-risk the commercial feasibility and on-time
delivery of this key Unilife project."
Comments by SVP Operations Bernhard Opitz
"Unilife undertook a comprehensive and highly detailed selection
process spanning almost twelve months to identify the right partner
to develop and supply the automated assembly systems that will
manufacture our Unifillâ„¢ syringes. Following the successful
completion of several critical proof-of-principle activities by
Mikron, we believe we have selected the partner with the right
level of industry experience and operational capabilities to
deliver this key project on-time and according to contract
specifications. We look forward to receiving Mikron's
highly-efficient automated assembly lines to help support the
manufacturing of our Unifill(TM) syringes for supply to
international pharmaceutical customers."
Comments by President Mikron Corporation Denver, Paul Kuchay
"It is with great pleasure that Mikron Assembly Technology
acknowledges the responsibility to partner with Unilife on this
ambitious program. For over 30 years we have delivered innovative,
reliable, efficient assembly solutions to the pharmaceutical and
medical device industries. The robust design of the Unifill(TM)
product strongly complements our proven automated assembly
technology. Mikron Corporation Denver will be partnering with
Mikron Assembly Technology division's headquarters in Boudry,
Switzerland in order to deploy and fulfil our commitments to the
customer's production schedule. We look forward to building a
strong relationship with a dynamic company such as Unilife."
About Unilife
Unilife Medical Solutions Ltd is an ISO 13485 certified company
that designs, develops and supplies innovative safety medical
devices. Listed on the Australian Securities Exchange (ASX: UNI)
since 2002, Unilife has FDA-registered manufacturing facilities in
the US State of Pennsylvania and a proprietary portfolio of
clinical and prefilled safety syringes designed for use within
healthcare and pharmaceutical markets.
Shareholder / Analyst Enquiries: Australia Jeff Carter Phone: +
61 2 8346 6500 United States Stuart Fine Phone: + 1 908 469
1788
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